MAUDE Adverse Event Report: LIMACORPORATE SPA SMR GLENOSPHERE Ø 40MM; GLENOSPHERE DIA. 40 MM

Model Number 1374.09.121

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Fluid Discharge (2686)

Event Date 02/22/2019

Event Type  Injury  

Manufacturer Narrative

By checking the sterilization charts of the involved lots, no pre-existing anomaly was found on the overall number.Therefore, we can ensure that all the products placed on the market with these lots have been properly sterilized before being placed on the market.Besides the event description, no additional info to be possibly recoverable for this case.Based on the check of the sterilization charts, we can rely this case is not product related.According to limacorporate pms data, revision rate of smr reverse prosthesis due to infection is (b)(4).Based on the root cause analysis performed and according to the relevant pms data, no corrective actions required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.

Event Description

Fourth revision surgery of a smr reverse prosthesis performed on (b)(6) 2019 due to suspected infection.According to the complaint source, on (b)(6) 2019 patient presented with copious amounts for drainage and was scheduled for a washout procedure on 22 february 2019.When in surgery, surgeon found no infection but a hematoma that caused the drainage.Implant were removed and new components were implanted.Patient had a history of shoulder problems and surgeries: a total of 7 complaints related to this patient (including this one) have been reported to limacorporate on april 15th, 2022: initial surgery (reverse prosthesis) on (b)(6) 2017; first revision surgery on (b)(6) 2018 (lima complaint # (b)(4)); second revision surgery on (b)(6) 2018 (lima complaint # (b)(4)); third revision surgery on (b)(6) 2019 (lima complaint # (b)(4), not reportable to fda); fourth revision surgery on (b)(6) (object of this report, (b)(4)); fifth revision surgery on (b)(6) 2019 (lima complaint # (b)(4)); sixth revision surgery on (b)(6) 2019 (lima complaint # (b)(4), not reportable to fda); dislocation to be solved with a compassionate use device (lima complaint # (b)(4), not reportable to fda).Event happened in us.

• Brand Name: SMR GLENOSPHERE Ø 40MM
• Type of Device: GLENOSPHERE DIA. 40 MM
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 14367116
• MDR Text Key: 294681108
• Report Number: 3008021110-2022-00034
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K163397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1374.09.121
• Device Lot Number: 1814499
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention